Department of Chemistry, Faculty of Sciences, Universitat Autònoma de Barcelona, E-08193 Bellaterra, Barcelona, Spain.
J Pharm Biomed Anal. 2013 Sep;83:265-72. doi: 10.1016/j.jpba.2013.05.016. Epub 2013 May 20.
In the present paper, we have developed two different approaches based on ion mobility spectrometry (IMS) for the cleaning validation of diacetyl midecamycin in the surfaces of manufacture equipment: a semi-quantitative approach based on the use of a sample wand and a quantitative procedure based on the swab test. The simultaneous determination of the active pharmaceutical ingredient and cleaning agents has been performed without important effects of ionization suppression upon the analysis of swabs containing multiple components. Sensitivity, in the ng range, and appropriate selectivity ratify IMS as a serious alternative, a fast and serious alternative in cleaning validation. Other advantage imply its potential for at-line use to perform a semi-quantitative procedure using a sample wand which allows Teflon membranes, swabbed onto the stainless steel surfaces, to be introduced directly into the instrument with no dilution or extraction.
在本论文中，我们开发了两种基于离子淌度谱（IMS）的不同方法，用于制造设备表面的二乙酰麦迪霉素的清洁验证：一种基于使用样品棒的半定量方法和一种基于棉签测试的定量方法。在分析含有多种成分的棉签时，活性药物成分和清洁剂的同时测定没有受到电离抑制的重要影响。在纳克范围内的灵敏度和适当的选择性证实 IMS 是一种替代方法，它是清洁验证的快速、严格的替代方法。其他优点表明，它有可能在线使用样品棒进行半定量程序，该程序允许将涂在不锈钢表面上的特氟龙膜直接引入仪器中，无需稀释或提取。
